Download PDF
Arzneimittelforschung 2010; 60(12): 776-779
DOI: 10.1055/s-0031-1296354
Special Themes
Editio Cantor Verlag Aulendorf (Germany)

Instructions and methods for clinical testing of drugs for the treatment of atrial fibrillation

Wink Konrad
1   Medical Faculty of the University of Freiburg, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
03 December 2011 (online)

    Permissions and Reprints

Abstract

Instructions and methods for clinical testing of drugs for the treatment of atrial fibrillation are the subject of this paper. Certain criteria must be considered to demonstrate the effectiveness and benefit/risk ratio of pharmacotherapy of atrial fibrillation for the planning and performance of clinical trials. These criteria include the various forms of atrial fibrillation, the corresponding definition of endpoints, the appropriate study design, randomization and blinding, and also the adequate dose, investigation methods, sample size determination, analysis, and early termination. Only the consideration of these criteria may allow an appropriate treatment decision.

Key words

Atrial fibrillation - Clinical drug testing, criteria - Clinical trials, planning and performance - Drug development, efficacy and safety
 

  • References

  • 1 Wink K. Anleitung und Methodik zur klinischen Prüfung von Arzneimitteln für die Therapie der chronischen Herzinsuffizienz. Arzneimittelforschung. 2008; 58: 475-9 German.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 2 Wink K. Anleitung und Methodik zur klinischen Prüfung von Arzneimitteln für die Therapie der stabilen peripheren arteriellen Verschlusskrankheit. Arzneimittelforschung. 2006; 56: 52-7 German
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 Wink K. Anleitungen und Methodik zur klinischen Prüfung von Arzneimitteln für die Therapie der stabilen Angina pectoris. Arzneimittelforschung. 2003; 53: 864-8 German
    Article in Thieme ConnectPubMedGoogle Scholar
  • 4 Murgatroyd FD, Camm AJ. Atrial fibrillation for the clinician. Clinical approaches to tachyarrythmia. Vol. 4 Armonk (NY): Futura Publishing Company, Inc.; 1995
    Google Scholar
  • 5 Neuzner J, Pitschner HF. Vorhofflimmern, Vorhofflattern. Aktuelle Diagnostik und Therapie. Darmstadt: Steinkopff; 2000
    Google Scholar
  • 6 Kingma JH, van Hemel NM, Lie KI. Atrial fibrillation, a treatable disease ? Developments in cardiovascular medicine. Vol. 139 Dordrecht, Boston: Kluwer Academic Publishers; 1992
    CrossrefGoogle Scholar
  • 7 Touboul P, Waldo AL. Atrial arrhythmias. Current concepts and management. St. Louis: Mosby Year Book; 1990
    Google Scholar
  • 8 Wink K. Therapie des Vorhofflimmerns. AVP Arzneiverordnung in der Praxis. 1996; 1
    PubMedGoogle Scholar
  • 9 Wink K. Grundlagen zur Durchführung von Arzneimittelstudien. Ratingen: PVV-Verlag; 2002
    Google Scholar
  • 10 EMEA (European Medicines Agency) Committee for Medicinal Products for Human use (CHMP): Note for Guidance on Anriarrhythmics, Addendum on Atrial Fibrillation. CPMP/EWP/237/95; London 24 July 2008
    PubMedGoogle Scholar
  • 11 Spilker B. Guide to clinical trials. New York: Raven Press; 1991: 464
    Google Scholar
  • 12 Hohnloser H, Crijns HJGM, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C et al for the Athena Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med. 2009; 360: 668-78
    CrossrefPubMedGoogle Scholar
  • 13 Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren no-given-name, Parekh A et al and the RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361: 1139-51
    CrossrefPubMedGoogle Scholar